FDA (Devices) recall action 86939

Fresenius Medical Care Holdings, Inc. recalled 11 products on 2021-01-20

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2021-01-20
Critical: 0
Units: 15,061

Why these products were recalled

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

HighFDA (Devices)··2021-01-20
Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and low calcium levels.
Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states
SevereFDA (Devices)··2021-01-20
Fresenius Naturalyte Liquid Acid Concentrate Recalled for Conductivity Deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below manufacturing specifications.
Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states
HighFDA (Devices)··2021-01-20
Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in conductivity and calcium concentration.
Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states
HighFDA (Devices)··2021-01-20
Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in sodium conductivity and calcium concentration.
Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states
HighFDA (Devices)··2021-01-20
Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in sodium conductivity and calcium concentration.
Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states
HighFDA (Devices)··2021-01-20
Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation
Fresenius Medical Care is recalling 123 bottles of Naturalyte Liquid Acid concentrate due to conductivity deviations and low calcium levels.
Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states
SevereFDA (Devices)··2021-01-20
Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below specification.
Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states
HighFDA (Devices)··2021-01-20
Fresenius Naturalyte Liquid Acid concentrate drums recalled for conductivity deviation
Fresenius Medical Care is recalling 224 drums of Naturalyte Liquid Acid concentrate due to deviations in conductivity and calcium concentration.
Product
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states
HighFDA (Devices)··2021-01-20
Fresenius Citrasate Liquid Acid Concentrate Recalled for Conductivity Deviation
Fresenius Medical Care is recalling Citrasate Liquid Acid concentrate bottles due to conductivity deviations and low calcium levels.
Product
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states
HighFDA (Devices)··2021-01-20
Fresenius Citrasate Liquid Acid concentrate drums recalled for conductivity deviation
Fresenius Medical Care is recalling two drums of Citrasate Liquid Acid concentrate due to deviations in sodium conductivity and calcium concentration.
Product
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states
HighFDA (Devices)··2021-01-20
Fresenius Naturalyte Liquid Acid concentrate drums recalled for conductivity deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate drums due to deviations in sodium conductivity and calcium concentration.
Product
Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Distribution
0 states